The pharmaceutical and other industries are heavily regulated by many standards worldwide. Many of these regulations are intended to prevent spoilage of valuable pharmaceuticals and food items due to prolonged exposure to unacceptably high temperatures, to contaminating atmospheres, or the like. For example, the Food and Drug Administration (FDA) of the United States regulates all quality control and details associated with manufacturing and production of pharmaceuticals. Many of these drugs must be kept within a narrow temperature range, most often 2 to 8° C., during shipment and storage. These drugs are stored in refrigerated warehouses, and often shipped in large trucks that also have carefully controlled refrigeration systems. A single shipment of drugs can be worth many millions of dollars and maintaining the drugs within this narrow temperature range becomes a critical issue. The Food and Drug Administration requires proof that a drug has been maintained within this narrow temperature range up to the time of sale.
Currently, warehouses and trucks are checked periodically using small reference battery-operated temperature sensor tags that log the temperature (for example, upon an internal read-write memory for subsequent reading and then re-use for storage of new readings). Such sensor tags, under the name Spectrum 2000, are available from Veriteq Instruments, Inc. of Richmond, British Colombia, in Canada. These sensors are placed at strategic places within a truck or a warehouse and the temperature over time is monitored. The sensor tags are removed from the warehouse and plugged into a computer where the data logging is harvested (read) and stored on a desktop computer system. The logger tags may then be reused. Proof must be maintained that each tag is accurate to within 0.25° C., and that the temperature tag has been recently calibrated. In addition, the software used to read the tag has many special features that seek to guarantee the data log has not been altered. As a result such reusable tags can cost between $300-$500 each, and the software and overhead of managing the data log and printouts can be quite expensive. As a result, current methods provide for event tracking of large groups of stored objects (e.g. an entire repository, such as a truck or warehouse), rather than smaller groups or even individual items. If an unacceptable temperature variation is detected at the sensor tag, the prior-art system requires destruction of a large group of items associated with that tag.
It would thus be desirable to provide a system that dramatically reduces costs and makes possible real-time tracking of temperatures (or other events) for warehouses, as well as trucks and other repositories, on a routine basis and for virtually every item (e.g. on a pallet basis or any other basis) that is contained in the truck or in the warehouse.
In the context of the present invention, the term “repository” shall be construed broadly to embrace all means of storage and shipment, including a warehouse, truck, airplane, oceangoing ship, and containers used for the foregoing. Moreover, the stored “objects” should be construed broadly to encompass all manner of goods, including pharmaceuticals, foodstuffs, wines and all other items whose condition responds to negative (e.g. high temperatures) or even positive events which they may experience.
The FDA has published a detailed specification (Guidance for Industry—Part 11, Electronic Records; Electronic Signatures—Scope and Application, August, 2003) for data logging and audit methods that aim to prove that the environmental event data has not been altered. The August/2003 FDA Guidance states at page 6 that the FDA “intends to exercise enforcement discretion regarding specific part 11 requirements related to computer-generated, time-stamped audit trails . . . . Persons must still comply with all applicable predicate rule requirements related to documentation of, for example, date . . . , time, or sequencing of events, as well as any requirements for ensuring that changes to records do not obscure previous entries.” This auditable authenticity of event histories is particularly critical in the pharmaceutical industry where an individual truck may contain many millions of dollars worth of freight and if the temperature strays outside the critical range for only four hours, then all the freight in the truck must be destroyed. Clearly, individuals involved in handling the event data may have a motivation to alter the data. Therefore, the audit trail and traceability of the audit trail is critical for a temperature tracking system.